Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Perennial Allergic Rhinitis Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974571
• Other study ID #: 0476-246
• Secondary ID: MK0476-2462009_6
• Status: Completed
• Phase: Phase 3
• Start date: November 2001
• Est. completion date: May 2002

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1365
• Est. completion date: May 2002
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient has a documented clinical history of perennial allergic rhinitis

• Patient is a nonsmoker

• Patient is in good general health

Exclusion Criteria:

• Patient is hospitalized

• Patient is a woman who is <8 weeks postpartum or is breast-feeding

• Patient is a current or past abuser of alcohol or illicit drugs

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• montelukast sodium
montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
• Comparator: cetirizine
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
• Comparator: placebo
placebo tablet orally once daily at bedtime for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Daytime Nasal Symptoms Score	Mean change from baseline in Daytime Nasal Symptoms score.; Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.	Baseline and first 4 weeks of a 6-week treatment period
Secondary	Mean Change From Baseline in Nighttime Symptoms Score	Mean change from baseline in Nighttime Symptoms Score.; Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.	Baseline and first 4 weeks in 6-week treatment period
Secondary	Mean Change From Baseline in Composite Symptoms Score	Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].	Baseline and first 4 weeks in 6-week treatment period
Secondary	Patient's Global Evaluation of Allergic Rhinitis	An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.	End of the first 4 weeks in 6-week treatment period
Secondary	Physician's Global Evaluation of Allergic Rhinitis	An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.	End of the first 4 weeks in 6-week treatment period